Green Vegetables and Women's Health

NCT01726127 | Completed

• 1 other identifier: 2011-0872
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The 2010 Dietary Guidelines for Americans recommend that individuals consume 4.5 to 5 cups fruits and vegetables daily. However, at current intake levels, fruit consumption will have to improve by more than 100% and vegetable intake by 50% to meet this recommendation. Importantly, intake of brightly colored fruits and vegetables is even lower when potatoes are not considered. It is possible that improved fruit and vegetable intake will have beneficial health effects. For example, higher intakes of fruits and vegetables, and particularly cruciferous vegetables (e.g., broccoli, Brussels sprouts, cauliflower, etc.), are associated with lower rates of many degenerative diseases, including some cancers, yet this group of vegetables may continue to be under-consumed due to their strong flavors. A supplement made from these vegetables (Cruciferous CompleteTM made by Standard Process Inc. Palmyra, WI) contains a group of phytochemicals called glucosinolates that can shift estrogen metabolism in a favorable way. One proposed biomarker of chemoprotection from breast cancer is the urinary estrogen metabolite ratio of 2- to 16α-hydroxyestrogens (2:16). In the main study, the effects of cruciferous vegetables (broccoli or Brussels sprouts), Cruciferous CompleteTM whole food supplements, or placebos on this ratio of urinary estrogen metabolites in healthy premenopausal women will be compared over an eight-week period. The investigators hypothesize that treatment with daily supplements will increase the 2:16 ratio as compared to daily consumption of a combination of Brussels sprouts and broccoli or a placebo, suggesting reduced breast cancer risk. In a sub-study, the relationships between serum α-carotene, β-carotene, β-cryptoxanthin, lutein and lycopene with dietary carotenoid intake as measured by a food frequency questionnaire and body composition will be evaluated in healthy premenopausal women. Carotenoids are a family of lipophilic compounds found primarily in colorful plant tissues and their concentration in human blood reflects dietary intake of carotenoid-rich foods. Carotenoid levels in the blood of healthy women do not appear to be influenced by menstrual status, but are inversely associated with body fatness. Thus, serum carotenoid concentrations may serve as a functional marker for chronic disease risk associated with excess body fat.

Conditions

Dietary Modification

Outcome Measures

Primary Outcomes (1)

• Urinary 2:16 ratio

  Urinary 2:16 ratios between treatment groups.

  8 weeks

Secondary Outcomes (1)

• Urinary 4OHE1 and 4OHE2

  8 weeks

Other Outcomes (5)

• Body composition

  8 weeks

• Stability of urinary 2:16 ratio.

  8 weeks

• Sub-study: Serum carotenoids and dietary intake

  One blood draw on one day

Study Arms (3)

Broccoli and Brussels Sprouts

EXPERIMENTAL

Subjects will consume broccoli or Brussels sprouts (40g daily) for 8 weeks.

Other: Broccoli and Brussels Sprouts

Cruciferous Complete

EXPERIMENTAL

Subjects will take Cruciferous CompleteTM supplements (2 capsules, 3 times daily) for 8 weeks.

Dietary Supplement: Cruciferous Complete

Placebo

PLACEBO COMPARATOR

Subjects will take placebo capsules (2 capsules, 3 times daily) for 8 weeks.

Other: Placebo

Interventions

Broccoli and Brussels Sprouts OTHER

Broccoli and Brussels Sprouts

Cruciferous Complete DIETARY_SUPPLEMENT

Cruciferous Complete

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal women between the ages of 40-50; premenopause is defined as regular menstrual cycles every 23-35 days
• Willing to be randomized and compliant to the 3 study groups (whole cruciferous vegetable intake, cruciferous supplement or placebo capsules)
• Able to give informed consent.

You may not qualify if:

• Urinary 2:16 \> or = 3.
• Current kidney or liver disease, adrenalectomy, or oophorectomy.
• Use of tobacco products within the preceding three months, illegal use of medications or use of illegal drugs or substances.
• Current use of antibiotics, cimetidine or black cohosh.
• Systemic administration of estrogen, or use of non-prescription hormones, tamoxifen, or diabetes medication within the last three months.
• Women under a physician-directed diet or those with a strong dislike of Brassica vegetables.
• Presence of cancer in the last 5 years, with the exception of fully resected basal or squamous cell tumors.
• Participation in an investigational drug study in the last 30 days.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Standard Process Inc.: collaborator

Study Sites (1)

University of Wisconsin Osteoporosis Clinical Research Program Clinic

Madison, Wisconsin, 53705, United States

Location

Study Officials

• Sherry A. Tanumihardjo, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Neil Binkley, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 14, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

US (1)